Gastrointestinal Cancers
Conditions
Brief summary
This project aims to evaluate the sensitivity and specificity of combined blood multi-gene methylation and fecal biomarkers for pan-digestive tract cancer screening, so as to establish a novel technical system for the early diagnosis of pan-digestive tract cancers.Individuals scheduled to receive digestive tract endoscopy are enrolled. Blood and stool samples are collected prior to endoscopic examination for detection of blood multi-gene methylation, fecal immunochemical test (FIT) and calprotectin. Endoscopic procedures are then performed. Following completion of baseline endoscopic screening, all enrolled participants will be followed up for 5 years. The primary endpoint of this study is the sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers in screening for pan-digestive tract cancers.
Interventions
None listed
Sponsors
Xijing Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
45 Years to 74 Years
Healthy volunteers
Yes
Inclusion criteria
* 1.Subjects aged 45-74 years at enrollment; 2.Scheduled to undergo digestive tract endoscopic screening; 3.Agree to receive five-year follow-up in accordance with the study protocol; 4.Willing to provide written informed consent.
Exclusion criteria
* 1\. Having received upper gastrointestinal endoscopy within one year; 2.History of any type of malignant tumor; 3.Complicated with severe illnesses that reduce screening benefits, such as severe pulmonary, renal, hepatic, cardiovascular, cerebrovascular and hematological diseases; 4.Other conditions assessed by physicians as excessively high risk for endoscopic screening (e.g., hemodynamic instability) or non-beneficial (short life expectancy); 5.Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity of blood multi-gene methylation combined with fecal biomarkers for pan-digestive tract cancer screening, with endoscopy plus pathological biopsy serving as the gold standard | Day 1 At endoscopy and pathological confirmation after enrollment |
| Specificity of combined biomarkers for pan-digestive tract cancer screening | Day 1 At endoscopy and pathological confirmation after enrollment |
Secondary
| Measure | Time frame |
|---|---|
| Detection rate of precancerous lesions of digestive tract by blood multi-gene methylation combined with fecal biomarkers. | 5 years after enrollment |
| Sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers for esophageal cancer screening | 5 years after enrollment |
| Sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers for gastric cancer screening | 5 years after enrollment |
| Sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers for colorectal cancer screening | 5 years after enrollment |
| Sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers in screening for high-grade intraepithelial neoplasia of esophageal mucosa and early esophageal cancer | 5 years after enrollment |
| Sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers for screening high-grade gastric mucosal intraepithelial neoplasia and early gastric cancer | 5 years after enrollment |
| Sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers for screening high-grade colorectal mucosal intraepithelial neoplasia and early colorectal cancer | 5 years after enrollment |
| Complications from endoscopic screening mainly include potential bleeding, perforation, infection, cardiovascular and cerebrovascular adverse events, aspiration, and screening-related mortality. | 5 years after enrollment |
Countries
China
Contacts
CONTACTRong Zheng
PRINCIPAL_INVESTIGATORYongzhan Nie
Xijing Hospital
Outcome results
None listed